Background Postoperative knee swelling is common and impairs early postoperative function following total knee arthroplasty. It was hypothesised that the use of a short-stretch, inelastic compression bandage would reduce knee swelling and improve pain and early function. The aim of this study was to provide preliminary data and test feasibility with a view to informing a larger, future trial. Methods Fifty consecutive patients selected for primary total knee arthroplasty underwent distance randomisation to receive a short-stretch, inelastic compression bandage or a standard wool and crepe bandage for the first 24 h postoperatively. Study feasibility including recruitment rates, retention rates and complications were analysed. The Oxford Knee Score, the EQ-5D-3L index score, knee swelling, knee range of motion, visual analogue pain score and length of stay were compared between groups. Analysis of covariance (ANCOVA) was performed adjusting for the preoperative measurement. Results Sixty-eight percent of eligible patients were recruited into the trial. The retention rate was 88%. There were no complications regarding compression bandage use. There was a greater mean but non-significant improvement in Oxford Knee Score (p = 0.580; point estimate = 2.1; 95% CI −3.288 to 7.449) and EQ-5D-3L index score (p = 0.057; point estimate = 0.147; 95% CI −0.328 to 0.005) in the compression bandage group at 6 months. There was no significant difference between groups regarding knee swelling, knee range of motion, visual analogue pain score, complications and length of stay. Conclusion Preliminary data suggests that the use of an inelastic, short-stretch compression bandage following total knee arthroplasty is a safe technique that is acceptable to patients. A larger, multicentre trial is required to determine its effect postoperatively. Trial registration The study was registered with Current Controlled Trials, identifier: ISRCTN86903140. Registered on 30 May 2013.

Brock et al. Trials
STICKS study - Short-sTretch Inelastic Compression bandage in Knee Swelling following total knee arthroplasty - a feasibility study
T. M. Brock 0
A. P. Sprowson 2
S. Muller 1
M. R. Reed 1
0 Trauma and Orthopaedic Surgery, Newcastle University , Newcastle upon Tyne NE1 7RU , UK
1 Wansbeck General Hospital, Northumbria Healthcare NHS Foundation Trust , Woodhorn Lane, Ashington NE63 9JJ , UK
2 Trauma and Orthopaedics, Warwick Clinical Trials Unit, University of Warwick , Coventry CV4 7AL , UK
Background: Postoperative knee swelling is common and impairs early postoperative function following total knee arthroplasty. It was hypothesised that the use of a short-stretch, inelastic compression bandage would reduce knee swelling and improve pain and early function. The aim of this study was to provide preliminary data and test feasibility with a view to informing a larger, future trial. Methods: Fifty consecutive patients selected for primary total knee arthroplasty underwent distance randomisation to receive a short-stretch, inelastic compression bandage or a standard wool and crepe bandage for the first 24 h postoperatively. Study feasibility including recruitment rates, retention rates and complications were analysed. The Oxford Knee Score, the EQ-5D-3L index score, knee swelling, knee range of motion, visual analogue pain score and length of stay were compared between groups. Analysis of covariance (ANCOVA) was performed adjusting for the preoperative measurement. Results: Sixty-eight percent of eligible patients were recruited into the trial. The retention rate was 88%. There were no complications regarding compression bandage use. There was a greater mean but non-significant improvement in Oxford Knee Score (p = 0.580; point estimate = 2.1; 95% CI −3.288 to 7.449) and EQ-5D-3L index score (p = 0.057; point estimate = 0.147; 95% CI −0.328 to 0.005) in the compression bandage group at 6 months. There was no significant difference between groups regarding knee swelling, knee range of motion, visual analogue pain score, complications and length of stay. Conclusion: Preliminary data suggests that the use of an inelastic, short-stretch compression bandage following total knee arthroplasty is a safe technique that is acceptable to patients. A larger, multicentre trial is required to determine its effect postoperatively.
Knee replacement; Arthroplasty; Compression bandage; Enhanced recovery; Fast track; Feasibility
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Trial registration: The study was registered with Current Controlled Trials, identifier: ISRCTN86903140. Registered
on 30 May 2013.
Background
Total knee arthroplasty is a common and highly
successful operation in the management of osteoarthritis.
However, postoperative knee swelling is a common problem
due to intra-articular bleeding and inflammation of
periarticular tissues [1]. This results in decreased functional
performance as a result of quadriceps weakness [2] and
arthrogenic reflex inhibition due to pain [3] which can
delay rehabilitation, increase hospital length of stay and
decrease patient-reported outcomes [4, 5]. Additionally,
excessive knee swelling is associated with increased rates
of wound dehiscence and infection [6].
Intraoperative techniques to reduce intra-articular
bleeding, such as surgical technique [7], tourniquets [8]
and medication [9] are features in enhanced recovery
programmes. However, postoperative methods, including
the use of a cold compress [10], cryotherapy [11], elastic
bandaging [12] and compression bandages [13, 14] have
had limited success.
Compression bandage therapy is the established
treatment of venous ulcers and lymphoedema [15, 16]. It is
hypothesised that the application of this external
compression aids venous return and reduces hydrostatic pressure
in the leg by (1) improving the efficacy of the calf-muscle
pump and (2) moving blood from the superficial to the
deep venous system, subsequently allowing movement of
fluid from the interstitial space. The use of inelastic
bandages are preferred in arthroplasty as they have a low,
tolerable resting pressure but a more effective activation
of the deep venous system and calf-muscle pump with
ambulation compared to their elastic counterparts [17].
The efficacy in total knee arthroplasty is still unclear
due to conflicting results in the medical literature and
heterogeneous methodology [13, 18–20]. We
hypothesised that the use of a compression bandage in total knee
replacement would improve postoperative pain, swelling
and functional outcomes. The aim of this study was (1)
to test study feasibility in the form of eligibility,
recruitment rate, attrition rates and bandage complications, (2)
to derive preliminary subjective and objective data and
(3) to derive a power calculation for the Oxford Knee
Score using preliminary data.
Methods
The study was a prospectively enrolled, randomised
controlled feasibility study conducted at two hospital
sites within Northumbria Healthcare NHS Foundation
Trust. Ethical approval was obtained (13/NE/0137)
and the study was registered with Current Controlled
Trials (ISRCTN86903140). A protocol paper with
complete methodology was published previously [21].
A Consolidated Standards of Reporting Trials
(CONSORT) flow chart (Fig. 1) was utilised.
Participant recruitment
Fifty patients selected for total knee arthroplasty were
enrolled in the study between November 2013 and June
2014. The inclusion criteria for the study included (1)
primary total knee arthroplasty for osteoarthritis, (2) age
over 18 years and (3) being able to provide written,
informed consent. Exclusion criteria included (1)
peripheral vascular disease characterised by an Ankle-Brachial
Pressure Index (ABPI) <0.8, (2) peripheral neuropathy
and (3) Body Mass Index (BMI) >40.
Patients were randomised on the day of surgery by
electronic distance randomisation using the website
http://www.sealedenvelope.com. The randomisation
process was done in random permuted blocks to allow
even balancing of the groups. Patients were allocated to
the control group or the compression bandage group.
There was no difference in baseline characteristics
(Table 1). Preoperative measurements (below) were
recorded prior to randomisation to reduce bias.
Control group
Patients underwent primary total knee arthroplasty under
the care of one of two consultant orthopaedic surgeons
(SM, MR). Surgery was performed under general
anaesthesia or spinal anaesthesia and sedation. Intra-venously
administered (IV) antibiotics (gentamicin 3 mg/kg and teicoplanin
400 mg IV) and tranexamic acid (30 mg/kg IV up to 2.5 g)
were administered and a tourniquet used. A Nexgen
cruciate-retaining total knee arthroplasty was used (Zimmer,
Swindon, United Kingdom) with Palacos R + G bone
cement (Heraeus Medical, Newbury, United Kingdom).
Intra-operative periarticular injections of 80 ml 0.125%
bupivacaine were infiltrated and a further 20-ml 0.125%
bupivacaine bolus given via intra-articular wound catheter after
wound closure. The skin was closed using surgical skin clips,
which were removed at 10 to 14 days post-operatively. A
hydrocolloid dressing (Aquacel Surgical, Convatec Ltd.,
Flintfield, UK) was used for the wound. Standard bandaging
consists of a soft inner layer (Soffban, BSN Medical Ltd.,
Brierfield, UK) applied from 10 cm below to 10 cm above
the patella with a 50% overlap of bandage, followed by a
similar outer layer of crepe bandage (BSN Medical Ltd.,
Brierfield, UK) prior to deflation of the tourniquet.
The bandage and wound catheter were removed at
24 h leaving the hydrocolloid wound dressing in situ.
This dressing stayed on until the clips were removed at
10–14 days. A cryocuff was used after 24 h.
Compression bandage group
Patients received a compression bandage over the
hydrocolloid surgical wound dressing instead of the routine
wool and crepe bandage. Following tourniquet removal a
soft inner layer (Soffban, BSN Medical Ltd., Brierfield,
UK) was applied from the toes to the groin on the
EQ-5D-3 L index score
Calf circumference (cm)
Visual analogue pain score
ROM range of movement
Fig. 1 Consolidated Standards of Reporting Trials (CONSORT) flow chart
affected leg with a 50% overlap of bandage. Following
this the outer compressive layer bandage (Actico
bandage, Activa Healthcare Ltd., UK) was applied firmly
over the top, again with a 50% overlap of bandage. The
bandage was pulled to full stretch before it was wrapped
around the leg to ensure adequate compression in the
application. It was applied after release of the tourniquet
by necessity due to its length up the thigh. To ensure
Table 1 Patient demographics. Standard deviations in parentheses
homogeneity in bandage application, the operating
surgeons were shown a training video on correct
application of the bandage and were given a tutorial on
bandage application with real-life bandage application
and feedback. The bandage was removed at 24 h post
surgery leaving the hydrocolloid wound dressing in
situ.
Study feasibility
Recruitment, retention and refusal rates were calculated.
The proportion of patients undergoing primary total
knee arthroplasty who did not meet the eligibility criteria
was also calculated to ensure this was not too restrictive.
Ease of application and tolerance of the compression
bandage was determined qualitatively by the operating
surgeons and patients, respectively. Potential adverse
risks associated with the use of the compression
bandage, such as pain, wound dehiscence and blistering,
were recorded and rates calculated.
Outcome measures
The Oxford Knee Score was measured preoperatively
and at 6 months in line with UK Health and Social Care
Programme Patient Reported Outcome Measures. The
EuroQol EQ-5D-3L questionnaire was measured
preoperatively and at 6 months.
Knee swelling and range of motion were measured
preoperatively, daily until discharge and at 6 weeks. Visual
analogue pain scores were recorded preoperatively, daily
until discharge (pre- and post-physiotherapy) and at 6 weeks.
Length of hospital stay, readmission rates and
complications were also recorded using hospital episode
statistic data.
Statistical analysis
A secure Excel database was used to record data
(Microsoft Inc., Albuquerque, NM, USA). Statistical analysis was
performed using SPSS version 23.0 (SPSS Inc., Chicago,
IL, USA).
For each outcome measure (Oxford Knee Score,
EQ5D-3L index score, knee swelling, range of motion,
visual analogue scale score) the two groups were compared
at each applicable set time point (preoperative, day 1,
day 2, 6 weeks, 6 months) using analysis of covariance
(ANCOVA) with the baseline preoperative measurement
set as the co-variate. Statistical significance was denoted
at p < 0.05.
A power calculation was performed based on the
mean and standard deviations of the Oxford Knee
Scores collected from this data to inform a future, larger
trial. The risk of a type 1 error was set at 0.05 and a type
II error at 0.20. The retention rate from feasibility data
was incorporated into the final sample size number to
allow for possible patient dropout.
Results
Study feasibility
Of the 94 total knee arthroplasties performed during the
time period, 20 (21%) did not meet the inclusion criteria.
Using the 74 eligible patients, the recruitment rate was
68% (n = 50). Thirty-two percent (n = 24) of patients
were seen in clinic but did not receive patient
information in a timely manner and were not enrolled. There
were no refusals of participation in the study.
During the trial, one patient was excluded from the
trial in the control group due to an unplanned complex
knee replacement which did not meet the inclusion
criteria. Two patients in the control group and four
patients in the compression bandage group did not
complete 6-month follow-up and could not be analysed
(dropout rate 12%) (Fig. 1).
There were no reported problems with bandage
application by the operating surgeons and the bandage was
well-tolerated by patients, with no reports of discomfort
or restriction. There were no reported skin
complications with the compression bandages.
Outcomes
1. Oxford Knee Score
There was a mean Oxford Knee Score improvement of
11.0 in the control group and 13.1 in the compression
bandage group. Whilst the point estimate (2.1) was
nearing the minimally clinically significant difference of
3.0, the change in score was not statistically significant
(p = 0.580; 95% CI −3.288 to 7.449) (Table 2)
2. EQ-5D-3L index
There was a mean improvement in the EQ-5D-3L
index score in the compression bandage group
compared to the control group at 6 months, but this was
not statistically significant (p = 0.057; point estimate
= 0.147; 95% CI −0.328 to 0.005) (Table 2)
3. Knee swelling
There was an increase in mean knee swelling in both
groups on day 1 post-operatively, which increased
further at day 2 post-operatively. However, these values
were close to pre-operative levels by week 6, with the
exception of the knee circumference in both groups.
There was, however, no significant statistical
difference between groups at any time point (Fig. 2)
4. Range of motion
There was a decline in mean range of motion
postoperatively in both groups, which decreased further
at day 2 post-operatively. However, similarly to knee
swelling, these values were close to pre-operative
levels by week 6. There was large variation in initial
measurements in both groups, reflecting the varying
degrees of restriction of the knee due to
osteoarthritis and fixed-flexion deformity. There was no
significant statistical difference between groups at any
time point (Fig. 3)
5. Pain scores
There was an improvement between pain scores in
both groups at 6 weeks compared to pre-operatively.
There was a small increase in pain scores in the
Table 2 Oxford Knee Score and EQ-5D-3L index measurements – standard deviations in parentheses. Point estimate refers to mean
difference between groups
Pre-op EQ-5D-3L index
6-month EQ-5D-3L index
6-month Oxford score
−0.328 to 0.005
−3.288 to 7.449
Fig. 2 Bar chart to show mean circumference (cm) of the leg pre- and post-total knee arthroplasty. Error bars represent interquartile range. No
statistical significance was found between groups at any time point
compression bandage group on day 1 and day 2 but
this was not significant. There was no significant
statistical difference in pain scores between groups
at any time point (Table 3)
6. Length of stay and complications
The mean length of stay was 3.3 days in the control
group and 3.1 days in the compression group (p =
0.749; point estimate = 0.2; 95% CI −0.815 to 1.125).
There were no registered infections or
thromboembolic events in either group
Discussion
The main finding of this feasibility study was that the
study was acceptable to patients with 68% recruitment
rate of eligible patients. Attrition was relatively low at
12% and the intervention was acceptable to patients with
no documented complications associated with the
bandage use.
In terms of clinical outcomes there was a greater mean
improvement in the Oxford Knee Score in the
compression bandage group. Whilst the 95% confidence interval
(−3.288 to 7.449) was wide it did include the three-point
difference associated with a clinically important
difference. There was a mean greater mean improvement in
EQ-5D-3L index scores at 6 months in the compression
bandage group, but this was not statistically significant
(p = 0.057; point estimate = 0.147; 95% CI −0.328 to
0.005). No statistical difference was found between the
groups regarding knee range of motion, knee swelling or
pain at any time point.
We accept that there are limitations with the current
study. With regards to the study protocol, it was not
possible to blind patients or investigators to the
intervention, which may introduce bias. Secondly,
interobserver variation is a known limitation of objective knee
measurements including range of motion and
Fig. 3 Bar chart to show mean total range of motion (degrees) of the leg pre- and post-total knee arthroplasty. Error bars represent inter-quartile
range. No statistical significance was found between groups at any time point
Day 1 pre physio
Day 1 post physio
Day 2 pre physio
Day 2 post physio
Table 3 Mean visual analogue pain score – standard deviations in parentheses. Point estimate refers to mean difference between groups
circumference. It is possible that this may account for
some of the variation between subjects and
consequently, in combination with the large sample size
required for the definitive trial, will not be used. Thirdly,
there was a large proportion of patients who were
eligible for the trial but not enrolled (32%). This was due
to the logistics of research nurse availability and not
patient demographics or comorbidities. All patients who
were approached regarding the trial agreed to
participate. Finally, whilst the primary aim was to ascertain
feasibility of the study, the study measurements were
underpowered and at risk of type II error. Using this
preliminary data for Oxford Knee Score, incorporating
attrition rate and standard deviation with 90% power, we
would need the following number of participants to
determine statistical significance: 354; 790; 3088 for a 3-,
2- and 1-point difference, respectively. These figures will
form the basis of the future multicentre study.
In a randomised controlled trial of 60 patients
undergoing unicondylar knee arthroplasty, Pinsornsak et al.
found no difference in swelling, blood loss or pain at
24 h and 48 h postoperatively between a modified
Robert-Jones bandage and a standard wool and crepe
bandage [19]. Whilst the bandaging technique was
different, the findings are similar to our study.
In contrast, Charalambides et al. found that patients
had improved range of motion (knee flexion) and
decreased length of stay when a compression bandage
was used [14]. However, the study of 150 patients
was not randomised and relied on retrospective data
in the cohort that received the standard wool and
crepe bandages. It was also not performed in an
enhanced recovery programme setting. A study by
Cheung et al. found similar findings regarding
improved knee flexion in the compression bandage
group, with associated lower incidence of walking aids
at discharge [20]. Anderson et al. found that the use
of a compression bandage and local anaesthetic
infiltration was associated with significant improvement
in pain scores at 8 h but not 24 h postoperatively
[13]. In our present study, no significant difference in
pain scores were seen 24 h postoperatively. The local
anaesthetic infiltration in both our groups may have
influenced this. There was a small, non-significant
increase in pain scores in the compression bandage
group during day 1 and day 2 post-operatively, but
this did not tally with qualitative information on the
bandage provided by the patients.
To our knowledge this is the first study to utilise
patient-reported outcome measures with the use of
compression bandages after total knee arthroplasty.
Whilst not statistically significant, the mean
improvement in Oxford Knee Score of 2.1 in the
compression bandage group is near the minimal
clinically significant difference for the Oxford Knee
Score [22]. The greater mean improvement in the
EQ-5D-3L index score (p = 0.057; point estimate =
0.147; 95% CI −0.328 to 0.005) in the compression
group also follows this trend. However, these results
should be interpreted with caution due to the small
sample size. As the compression bandage was easy
to apply and well-tolerated by patients, without any
documented complications, further investigation of
its use in a larger, multicentre trial is warranted.
Conclusion
Feasibility data suggests that the compression bandage is
easy to use and well-tolerated. No statistically significant
differences were seen for post-operative scores between groups.
However, there was a marginal trend to an improvement in
patient-reported outcome measures at 6 months in the
compression bandage group. Future work should be
directed at further investigation of these patient-reported
outcome measures in a larger, multicentre trial.
Acknowledgements
The authors are very grateful to York Trials Unit, UK for the definitive trial power
analysis and manuscript advice. The authors would like to thank the
participants involved in the study and the research team, Chris Herriot (clinical
research nurse), Clare Casson and Diane Williams (senior physiotherapists).
Availability of data and materials
Data available on request.
Authors’ contributions
This manuscript outlines independent investigator-initiated research. The views
expressed are solely those of the authors. MR conceived the study, designed
the study, participated in recruitment and reviewed the manuscript. TB
designed the study, participated in recruitment and wrote the manuscript. AS
designed the study. SM participated in recruitment and reviewed the manuscript.
With the exception of AS, who is now deceased, all authors were involved in
drafting the manuscript and revising it for important intellectual content and give
permission for this version to be published.
Ethical approval and consent to participate
Ethical approval was obtained (13/NE/0137) and the study was registered
with Current Controlled Trials (ISRCTN86903140). Informed consent was
given by all participants.
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